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引用本文:赵振霞,王敏,刘永利,冯丽.心可舒片的质量控制[J].中国现代应用药学,2015,32(7):820-823.
ZHAO Zhenxia,WANG Min,LIU Yongli,FENG Li.Study on Quality Control of Xinkeshu Tablet[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(7):820-823.
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心可舒片的质量控制
赵振霞, 王敏, 刘永利, 冯丽
河北省药品检验研究院,石家庄 050011
摘要:
目的 建立心可舒片的质量控制方法。方法 采用高效液相色谱法对山楂中黄酮类成分进行定性鉴别,对木香中主要成分木香烃内酯与去氢木香内酯进行定量测定。结果 鉴别方法分离度良好;木香烃内酯和去氢木香内酯与相邻峰完全分离;线性关系良好,平均加样回收率(n=9)分别为99.99%(RSD=1.3%)和99.68%(RSD=1.1%)。结论 该方法专属性强、准确度高、重复性好,可用于心可舒片的质量控制。
关键词:  心可舒片  山楂  木香  木香烃内酯  去氢木香内酯  高效液相色谱法
DOI:
分类号:
基金项目:“重大新药创制”国家科技重大专项(2012ZX09304005-005);河北省科技计划项目(13272513)
Study on Quality Control of Xinkeshu Tablet
ZHAO Zhenxia, WANG Min, LIU Yongli, FENG Li
Hebei Institute for Drug Control, Shijiazhuang 050011, China
Abstract:
OBJECTIVE To establish the method for quality control of Xinkeshu tablet. METHODS Compositions of flavonoids in Crataegi Fructus was identified by HPLC. Costunolide and dehydrocostus lactone in Aucklandiae Radix were determined by HPLC. RESULTS The resolution of identification method was favorable. Costunolide and dehydrocostus lactone were separated literally. The linear relationships of calibration curves were favorable. The average spotting recoveries(n=9) of costunolide and dehydrocostus lactone were 99.99%(RSD=1.3%) and 99.68%(RSD=1.1%). CONCLUSION The established methods have favorable specificity, accuracy and repeatability, and can be applied for quality control of Xinkeshu tablet.
Key words:  Xinkeshu tablet  Crataegi Fructus  Aucklandiae Radix  costunolide  dehydrocostus lactone  HPLC
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